Control submission pack

Learning objectives

• Assemble a Control submission pack that sustains the gain.
• Prove ownership transfer to the process owner.
• Show validated benefits and a working reaction plan.

Required evidence

• Control plan
• SOP and standard work
• Poka-yoke or robust design
• Visual triggers and reaction plan
• SPC where valid
• Repeat MSA
• Sustained capability
• Training and adoption evidence
• Validated benefits
• Handover, audit cadence and CAPA route

Copy-friendly Control pack checklist

• Control plan lists owner, frequency, record, trigger, reaction and escalation
• Reaction plan challenge-tested
• Competence confirmed (not just attendance)
• Sustained performance across representative period
• Process owner accepts handover in writing

Garment-factory example

A needle-life control specifies owner, replacement frequency, log record, abnormal-trigger response, containment, correction, restart and escalation across all shifts. The plan is challenge-tested with a deliberate abnormality before closure.

Method

1. Co-design controls with process owner and operators.
2. Confirm competence through observed performance.
3. Monitor for a representative duration before closure.

Common mistakes

• Closing on pilot data.
• Documents that differ from actual gemba practice.
• Treating training attendance as competence.